Sanofi gets green light as patent on its top-selling insulin is set to expire.

The FDA has approved Sanofi's follow-up to its top-selling basal insulin glargine (Lantus), a more concentrated (U300), once-daily basal formulation called Toujeo, as the patent on the original drug is set to expire.

That release did not offer data or comment on hypoglycemia, only referencing that "rates of severe and documented symptomatic hypoglycemia can be found on the label" -- even though experts previously contacted by MedPage Today had said that one advantage of the new formulation could be that it leads to less hypoglycemia.

The race is on to capture market share as patent expiration on Lantus is imminent. Last August, the FDA granted Eli Lilly and Boehringer Ingelheim "temporary" approval of its "biosimilar" insulin glargine, branded as Basaglar, as soon as it resolves ongoing patent infringement litigation with Sanofi.

FDA can't give final approval on the Lilly and Boehringer drug until mid-2016, unless the court finds in their favor earlier.

The copycat insulin glargine was approved through the FDA's 505(b)(2) regulatory pathway, not its typical generic or biosimilar pathway, although it is considered a biosimilar in Europe.

The fact that Toujeo is a more concentrated (U300) form of insulin signals increasing interest in more concentrated formulations -- which may be in higher demand as patients are becoming more obese and insulin resistant.

The most common side effects of Toujeo -- excluding hypoglycemia, the release notes -- were nasopharyngitis and upper respiratory tract infection. It is set to hit the market in the second quarter of 2015.

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